OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM— 510(k) K944391

Name: FDA 510(k) clearance K944391
Creator: U.S. Food and Drug Administration
Published: 1995-02-07

Substantially Equivalent

Surgitek

FDA 510(k) clearance K944391 for OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM, Substantially Equivalent on 1995-02-07. Applicant: Surgitek. Device class: 2.

Clearance details

Applicant: Surgitek
Product code: Code FEN
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1994-09-09
Decision date: 1995-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Racine, WI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.